Recalls / —

—#184746

Product

MiniCap Extended Life PD Transfer Set

FDA product code

KDJ — Set, Administration, For Peritoneal Dialysis, Disposable

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K192705

Affected lot / code info

Product Code: 5C4482, UDI: 00085412007731, Lot#, Expiration Date: H20D13100, 4/13/2025; H20D27084, 4/27/2025; H20D30070, 4/30/2025; H20E13107, 5/13/2025; H20E19054, 5/19/2025; H20E22082, 5/22/2025; H20F09061, 6/9/2025; H20F15050, 6/15/2025; H20F18070, 6/18/2025; H20F24086, 6/24/2025; H20F29051, 6/29/2025; H20G13046, 7/13/2025; H20G27087, 7/27/2025; H20G30065, 7/30/2025; H20H05057, 8/5/2025; H20H14067, 8/14/2025; H20H19066, 8/19/2025

Why it was recalled

Potential for no-flow and leaks under the twist clamp.

Root cause (FDA determination)

Process change control

Action the firm took

Urgent Medical Device Recall FA-2020-055 was sent to Peritoneal Dialysis Centers via U.S.P.S., first class mail on November 10, 2020. Urgent Medical Device Recall FA-2020-055 was sent via U.S.P.S., first class mail on November 13, 2020 to Home Patients who received impacted lots directly from Baxter. Out of an abundance of caution, Baxter will also be mailing the communication to all home patients who receive treatment at Peritoneal Dialysis Centers which received the impacted lots of transfer sets, regardless if the patient received the set or not.

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia

Timeline

Recall initiated

2020-11-10

Terminated

2023-03-24

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #184746. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.